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PEPG 資訊
PEPG 事件
PepGen CEO Highlights FREEDOM2 Clinical Progress
"During the second quarter, our team maintained a strong focus on execution as we advanced FREEDOM2 and continued preparing for our next clinical data readout," said James McArthur, PhD, President and Chief Executive Officer of PepGen. "The DSMB's recommendation to dose escalate in both FREEDOM2 and the open-label extension reflects the encouraging safety profile of PGN-EDODM1 following several months of repeat dosing. We look forward to initiating enrollment in the 12.5 mg/kg cohort shortly and sharing data from the 10 mg/kg cohort in November. We remain confident that repeat dosing has the potential to build on the clinical foundation established in the FREEDOM single-ascending dose trial as we continue evaluating the safety and benefits of PGN-EDODM1 for individuals living with DM1."
PepGen Advances PGN-EDODM1 to Third Phase
PepGen announced that an independent Data and Safety Monitoring Board, DSMB, has recommended advancing the ongoing Phase 2 FREEDOM2-DM1 study evaluating PGN-EDODM1 in participants with myotonic dystrophy type 1 into the third and highest multiple ascending dose, MAD, cohort of 12.5 mg/kg, with no recommended changes to the study protocol. The DSMB also recommended dose escalation in the open-label extension, OLE, study from 5 mg/kg to 10 mg/kg. Notably, 6 of 8 participants from the 5 mg/kg FREEDOM2 cohort have elected to enroll in the OLE, bringing total OLE enrollment to 16 participants. The recommendation followed a review of available safety data from the fully enrolled 10 mg/kg MAD cohort and the OLE study. The Company expects to report results from the fully enrolled 10 mg/kg FREEDOM2 cohort in November. Results from the 12.5 mg/kg cohort are expected in the first half of 2027, at which time PepGen plans to engage with regulators in an end of Phase 2 meeting to discuss plans for the registrational program. The Company also expects to provide an update from the OLE study by early January.
PepGen Files $400M Mixed Securities Shelf
PepGen files $400M mixed securities shelf
PepGen Reports Encouraging Progress in FREEDOM2-DM1 Trial
"We made encouraging progress during the first quarter of 2026 in our FREEDOM2-DM1 trial. The 5 mg/kg cohort - the initial dose cohort - demonstrated a favorable tolerability profile and promising efficacy trends, reinforcing our confidence in PGN-EDODM1's potential at higher doses," said James McArthur, PhD, President and Chief Executive Officer of PepGen. "Enrollment in the 10 mg/kg cohort is now complete and we remain on track to report data in the second half of this year. With funding in place through the 10 and 12.5 mg/kg cohorts, we are well positioned to continue dose escalating and deliver on the promise of this program for the DM1 community."
Investor Sentiment Affected by Middle East, S&P 500 Declines 0.4%
Investor sentiment continues to hinge on developments out of the Middle East, and the market is still not buying the latest salvo from President Trump that U.S. negotiators are in "serious discussions" to end the war. After opening broadly higher, indices ended the day mixed, with S&P 500's decline of 0.4% bringing the benchmark index within a percentage point of an official correction territory. While the Vix retreated modestly, it remains above the 30 handle, and while Treasury yields saw a sharp reversal from the steel ascend since the start of the Iran campaign, the 10-year is still over 30bps higher as traders remains concerned by the inflationary slowdown as a result of rising energy prices. Cyclical Industrials and Technology sectors were the worst performers, while defensively-oriented Staples and Utilities outperformed. In the evening hours, futures are little changed, though commodities are showing continued strain, with WTI Crude Oil futures up for fourth straight session, topping $104 per barrel.Check out this evening's top movers from around Wall Street, compiled by The Fly.HIGHER AFTER EARNINGS -Spruce Powerup 6.0%Progress Softwareup 1.3%DOWN AFTER EARNINGS -Phreesiadown 22.0%CVD Equipmentdown 10.8%Lantern Pharmadown 6.9%ALSO LOWER -PepGendown 44.4% after Phase 2 Freedom trial data
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